Benlysta treats active systemic lupus erythematosus (SLE) and lupus nephritis in people aged 5 years and older. The medication is administered via subcutaneous injection or intravenous infusion every 1 to 2 weeks, depending on patient age.
What Is Benlysta? Quick Facts
✅ Generic Name: Belimumab
✅ FDA Approved: March 9, 2011
✅ Used For: Systemic lupus erythematosus (SLE) & lupus nephritis
✅ Age Range: Adults & children (5+ years)
✅ Administration: IV infusion or subcutaneous (under-the-skin) injection
✅ How It Works: Blocks B-lymphocyte stimulator (BLyS) to reduce harmful antibodies
Table of Contents
Benlysta Dosage Guide (Table Format)
| Form | Age/Weight | Dosage for SLE | Dosage for Lupus Nephritis |
|---|---|---|---|
| IV Infusion | Adults & kids (5+) | 10 mg/kg every 2 weeks (first 3 doses), then monthly | 400 mg weekly (first 4 weeks), then 200 mg weekly |
| Auto-Injector (SC) | Adults | 200 mg weekly | 200 mg weekly |
| Auto-Injector (SC) | Kids (15–40 kg) | 200 mg every 2 weeks | 200 mg weekly (first 4 weeks), then every 2 weeks |
| Auto-Injector (SC) | Kids (40+ kg) | 200 mg weekly | Same as adults |
FDA Approval History
Benlysta (belimumab) was approved by the FDA on March 9, 2011. No generics or biosimilars are currently available.
Approved Uses
Benlysta is indicated for adults and children aged 5 and above with active SLE or lupus nephritis, when used alongside standard therapy. It is not approved for severe active central nervous system lupus due to insufficient data. The autoinjector is suitable for individuals aged 5+ and weighing at least 15 kg. The prefilled syringe is not studied in those under 18.
How Benlysta Works for Lupus
Benlysta targets B-lymphocyte stimulator (BLyS), a protein that keeps harmful B-cells alive. By blocking BLyS:
✔ Reduces autoantibodies attacking healthy tissue
✔ Lowers lupus flare-ups
✔ Helps with fatigue, joint pain, and kidney damage (lupus nephritis)
Who Should NOT Take Benlysta?
- People with severe CNS lupus (not enough data)
- Those with active infections
- Patients allergic to belimumab
Benlysta Side Effects
Common Side Effects
- Nausea,
- diarrhea
- Fever,
- sore throat
- Injection site reactions (redness, itching)
- Headaches,
- insomnia
- Mild depression
Serious Side Effects (Seek Help Immediately)
🔴 Severe infections (fever, chills, painful urination)
🔴 Allergic reactions (swelling, trouble breathing, rash)
🔴 Mental health changes (suicidal thoughts, severe depression)
🔴 PML (rare brain infection) – memory loss, vision changes
🔴 Increased cancer risk (due to immune suppression)
Benlysta Cost & Financial Assistance
- With insurance: Copay as low as $5/month
- Without insurance: $2,500–$3,500/month
- Patient Assistance Programs:
- GSK Patient Access (1-866-728-4368)
- Benlysta Copay Card (Covers up to $15,000/year)
Benlysta vs. Other Lupus Treatments
| Treatment | How It Works | Administration | Best For |
|---|---|---|---|
| Benlysta | Blocks BLyS protein | IV or self-injection | SLE & lupus nephritis |
| Saphnelo | Targets interferon | IV infusion | Moderate-to-severe SLE |
| Plaquenil | Immune modulator | Oral pill | Mild lupus symptoms |
| CellCept | Suppresses B-cells | Oral pill | Lupus nephritis |
